Chlorhexidine-Alcohol versus Povidone-Iodine for Surgical-Site Antisepsis

N Engl J Med. 2010 Jan 7;362(1):18-26. doi: 10.1056/NEJMoa0810988.

Abstract

Background: Since the patient's skin is a major source of pathogens that cause surgical-site infection, optimization of preoperative skin antisepsis may decrease postoperative infections. We hypothesized that preoperative skin cleansing with chlorhexidine-alcohol is more protective against infection than is povidone-iodine.

Methods: We randomly assigned adults undergoing clean-contaminated surgery in six hospitals to preoperative skin preparation with either chlorhexidine-alcohol scrub or povidone-iodine scrub and paint. The primary outcome was any surgical-site infection within 30 days after surgery. Secondary outcomes included individual types of surgical-site infections.

Results: A total of 849 subjects (409 in the chlorhexidine-alcohol group and 440 in the povidone-iodine group) qualified for the intention-to-treat analysis. The overall rate of surgical-site infection was significantly lower in the chlorhexidine-alcohol group than in the povidone-iodine group (9.5% vs. 16.1%; P=0.004; relative risk, 0.59; 95% confidence interval, 0.41 to 0.85). Chlorhexidine-alcohol was significantly more protective than povidone-iodine against both superficial incisional infections (4.2% vs. 8.6%, P=0.008) and deep incisional infections (1% vs. 3%, P=0.05) but not against organ-space infections (4.4% vs. 4.5%). Similar results were observed in the per-protocol analysis of the 813 patients who remained in the study during the 30-day follow-up period. Adverse events were similar in the two study groups.

Conclusions: Preoperative cleansing of the patient's skin with chlorhexidine-alcohol is superior to cleansing with povidone-iodine for preventing surgical-site infection after clean-contaminated surgery. (ClinicalTrials.gov number, NCT00290290.)

Publication types

  • Multicenter Study
  • Randomized Controlled Trial

MeSH terms

  • 2-Propanol / adverse effects
  • 2-Propanol / therapeutic use*
  • Adult
  • Analysis of Variance
  • Anti-Infective Agents, Local / adverse effects
  • Anti-Infective Agents, Local / therapeutic use*
  • Antisepsis / methods
  • Chlorhexidine / adverse effects
  • Chlorhexidine / analogs & derivatives*
  • Chlorhexidine / therapeutic use
  • Cross Infection / prevention & control
  • Drug Combinations
  • Female
  • Humans
  • Kaplan-Meier Estimate
  • Logistic Models
  • Male
  • Middle Aged
  • Polymerase Chain Reaction
  • Povidone-Iodine / adverse effects
  • Povidone-Iodine / therapeutic use*
  • Risk Factors
  • Skin / microbiology
  • Surgical Wound Infection / epidemiology
  • Surgical Wound Infection / microbiology
  • Surgical Wound Infection / prevention & control*

Substances

  • Anti-Infective Agents, Local
  • Drug Combinations
  • Povidone-Iodine
  • chlorhexidine gluconate
  • 2-Propanol
  • Chlorhexidine

Associated data

  • ClinicalTrials.gov/NCT00290290